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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / April 2026 / K252229

510(k) cleared

BELLIGER ACE

Genoray Co., Ltd. · Apr 2, 2026 · K252229

FDA cleared the BELLIGER ACE from Genoray Co., Ltd. on Apr 2, 2026 under K252229, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 16, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Genoray Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252229?

K252229 is the FDA 510(k) for BELLIGER ACE, submitted by Genoray Co., Ltd.. FDA's decision date was Apr 2, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the BELLIGER ACE?

Genoray Co., Ltd., based in Seongnam-Si, is the applicant of record for K252229.

How long did the K252229 review take?

FDA received the submission on Jul 16, 2025 and issued its decision on Apr 2, 2026, 260 days later.

← All decisions in April 2026